The assessment of interstitial low-dose rate brachytherapy in localized prostate cancer will be performed by the Institute for Quality and Efficiency in Health Care

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In February, 2018, the Federal Joint Committee (G-BA) has commissioned an assessment of the interstitial low-dose rate (LDR) brachytherapy in localized prostate cancer to the Institute for Quality and Efficiency in Health Care (IQWiG) in order to search, analyze and evaluate the current knowledge on this technology.

The following aspects should be considered for the assessment:

  • Target population: patients in localized prostate cancer (stages for both local and systemic cancer were included);
  • Specification of the method (intervention): treatment with an interstitial low-dose rate (LDR) brachytherapy;
  • Comparative treatments: standard surgical intervention (radical prostatectomy), percutaneous radiotherapy, observational strategies (e.g., active surveillance, watchful waiting);
  • Outcomes (especially patient-relevant outcomes), including mortality, morbidity, quality of life, side effects and complications.

If the relevant economic studies are identified, the information will be sent to G-BA for further evaluation.

The results should be delivered to the G-BA until September, 2018.

See full details in German here.

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10

Aug 2018

An article “An early analysis of cost-utility of baroreflex activation therapy in advanced chronic heart failure in Germany” was published in the BMC Cardiovascular Disorders. The study concluded that Baroreflex activation therapy (BAT) using the Barostim neo™ device (CVRx Inc., Minneapolis, MN, USA) compared with optimized medical management in patients with advanced chronic heart failure (NYHA class III) who were not eligible for treatment with cardiac resynchronization therapy, can be cost-effective from a statutory health insurance perspective in Germany over a lifetime horizon. The ICER was €27,951/QALY (95% CI €21,357–82,970).

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11

Jul 2018

In the second half of May, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance for low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy and endoscopic bipolar radiofrequency ablation for treating biliary obstruction caused by cancer.

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09

Jul 2018

Two mini-method assessments regarding brachytherapy for esophageal cancer and targeted gene deep-sequencing panels were initiated by Oslo University Hospital in May of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

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05

Jul 2018

Payment-for-performance schemes in health care remain controversial as there is no solid evidence that they improve quality of care. A new study, published in Health Policy by Herbst et al, did not show any positive long-term effects of the implementation of P4P on quality of care. The program was implemented within the integrated contract framework between one ophthalmological clinic and one statutory health insurance company in Germany.

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03

Jul 2018

In April of 2018, the Institute for Quality and Efficiency in Health Care (IQWiG) has published an update for the report V14-03 “Systematic guideline search and appraisal, as well as extraction of relevant recommendations, for a disease management program (DMP) for osteoporosis” from 2016 in order to find additional evidence on integrated concepts of medical and physical rehabilitation. However, no new information was identified and included into the report.

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22

Jun 2018

On the 23rd of May of 2018, the Institute for Quality and Efficiency in Health Care (IQWiG) has published an update version of the report “Colorectal cancer screening in persons with familial risk”, which was commissioned to IQWiG by the Federal Joint Committee (G-BA) in October of 2017 to provide an answer, whether people under 55 years of age with a family history of colorectal cancer benefit from a screening test. Like the previous report, the current one therefore concluded that the benefit of screening for under 55-year-olds with a family history of colorectal cancer is unclear.

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19

Jun 2018

On the 29th of May of 2018, the Institute for the Hospital Remuneration System (InEK) has published a joint document with G-DRG proposals for 2019. According to the decision made on the basis of § 17b KHG, the names of the applicants and procedure proposals for 2019 were provided.

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07

Jun 2018

In May of 2018, the Federal Joint Committee (G-BA) approved two additional indications for application of PET/CT for management of malignant lymphomas for coverage within statutory health insurance. As the procedures were included into Directive for methods and examinations and Directive methods of the contract medical care, they are now reimbursed in both hospital and out-patient settings.

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01

Jun 2018

European Med Tech and IVD Reimbursement Consulting Ltd. released a report, which identifies and provides an overview of the innovative payment schemes for medical devices and in-vitro diagnostic tests in European countries. The report was supported by the grant from the Med Tech Europe. Access the full version of the report at our web-site.

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01

Jun 2018

On the 9th of May of 2018, the addendum H18-01 to the report H16-02C “Ultrasound-guided high-focused ultrasound (USgHIFU) therapy for malignant neoplasms of the pancreas” commissioned by the Federal Joint Committee (G-BA) at the beginning of March of 2018, was published by the Institute for Quality and Efficiency in Health Care (IQWiG) on its web-site.

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28

May 2018

The call for a tender to select an organization to run the pilot study “Liposuction for the treatment of lipedema” was announced by the Federal Joint Committee (G-BA) on the 8th of May of 2018. The deadline for the requests is the 26th of June, 2018, 14:00.

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25

May 2018

On the 26th of April of 2018, the Federal Joint Committee (G-BA) has announced the call for a tender for the pilot study “Transcorneal Electrical Stimulation in Retinitis Pigmentosa” in the Official Journal of the European Union. The deadline for the requests is the 22nd of June, 2018, 14:00

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23

May 2018

On the 26th of April of 2018, the Federal Joint Committee (G-BA) has commissioned to the Institute for Quality and Efficiency in Health Care (IQWiG) to provide a rapid report regarding the current state of medical knowledge on synchronous balneophototherapy in atopic eczema. The identified results of the current state of medical knowledge would form the basis for the further G-BA’s assessment of adequacy, appropriateness and economic benefits of the researched method.

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09

May 2018

This is an updated version of the National Clinical Guidelines for the Treatment of Brain Metastases published in 2014.

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07

May 2018

On the 19th of April of 2018, the Federal Joint Committee (G-BA) was able to reassess previously excluded use of extracorporeal shockwave therapy (ESWT) in the indication of heel pain in plantar fasciitis on a current scientific basis and decided that ESWT will be used in out-patient settings in the future.

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02

May 2018

At the end of March of 2018, the Institute for Quality and Efficiency in Health Care (IQWiG) has released an updated version of the disease management program (DMP) “Coronary heart disease”, which was initially implemented in 2003.

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17

Apr 2018

The Institute for Quality and Efficiency in Health Care (IQWiG) has selected four out of 31 themes for the future health technology assessments, which were proposed by the citizens at the web-site of ThemenCheck Medizin service and will presumably be published at the beginning of 2019. The next process of topics’ selection will start in August of 2018.

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11

Apr 2018

Eight reimbursement reports with the total size of 882 pages cover the most common radiotherapy modalities including brachytherapy, 3D conformal radiation therapy, stereotactic radiosurgery, stereotactic body radiation therapy, intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT), image-guided radiotherapy, proton therapy. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 12 EU countries including Austria, Belgium, Denmark, England, Finland, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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09

Apr 2018

In April 2018, Danish Health Authority published 163 new codes for the Health Care Classification System, including five diagnosis codes, 34 surgical and 29 medical procedure codes. These codes are used to classify procedures in Danish DRG system.

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05

Apr 2018

The Federal Joint Committee (G-BA) has published two calls for tenders in the Official Journal of the European Union to select evaluator for two coverage with evidence development studies for pulmonary artery pressure measurement and monitoring using an implanted sensor to optimize therapy in NYHA class III heart failure and allogeneic stem cell transplantation for front-line treatment of multiple myeloma.

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27

Mar 2018

The background for updating the National Clinical Guideline for Treatment of Brain Metastases is that local treatment (stereotactic radiation therapy) has gained more space in the treatment of brain metastases.

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26

Mar 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In February new codes for preparation and delivery of radiotherapy, knee resurfacing arthroplasty, balloon dilatation of the Eustachian tube and MRI-guided focused ultrasound (MRgFUS) thalamotomy for essential tremor were added to the CCSD Schedule.

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21

Mar 2018

The Institute for Quality and Efficiency in Health Care (IQWiG) released the final report on the assessment of benefit for telemonitoring of cardiac implantable electronic devices compared to a standard treatment without telemonitoring in patients with ventricular tachyarrhythmias and / or heart failure. It was concluded that the benefits of the telemonitoring for patients with cardiac failure or heart rhythm disorders with a fast heart rate remain unclear.

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19

Mar 2018

In January 2018, the Institute for the Hospital Remuneration System (InEK) has published the List of the requests for innovation funding (NUB). Out of 705 requests for drugs and technologies, 171 (24%) received the positive status 1, and 72 of them were the requests for the medical technologies.

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15

Mar 2018

The German Federal Joint Committee (G-BA) has commissioned the Institute for Quality Assurance and Transparency in Health Care (IQTIG) to evaluate the guideline on minimally invasive heart valve interventions with minimum quality standards for hospitals that want to perform transcatheter aortic valve implantation (TAVI) or clip procedures on the mitral valve. The report has to be submitted by December, 2019.

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22

Feb 2018

In March 2013, the National Association of Statutory Health Insurance Funds requested a benefit assessment of surgical lung volume reduction in severe pulmonary emphysema. The Joint Federal Committee (G-BA) decided on February 15th 2018 that the method will remain a benefit in the inpatient sector in Germany. The was supported by a health technology assessment provided by the Institute for Quality and Efficiency in Health Care (IQWiG).

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20

Feb 2018

The method was under assessment by the Joint Federal Committee (G-BA) previously but the assessment was paused due to insufficient evidence in 2008. The final decision will concern the reimbursement of the method in the outpatient sector. The Institute for Quality and Efficiency in Health Care (IQWiG) is mandated to provide a health technology assessment (HTA) report to support G-BA’s decision.

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13

Feb 2018

The background for updating the National Clinical Guideline for Treatment of Brain Metastases is that local treatment (stereotactic radiation therapy) has gained more space in the treatment of brain metastases.

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09

Feb 2018

In order to decide upon the inclusion of medical benefits into the German statutory health insurance, the Joint Federal Committee (G-BA) can commission the Institute for Quality and Efficiency in Health Care (IQWiG) with the preparation of health technology assessments (HTA). At the turn of the year, IQWiG published its 220th evaluation dossier since its foundation in 2004. G-BA followed IQWiG’s recommendations in 70% of cases.

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25

Jan 2018

The German Institute of Medical Documentation and Information (DIMDI) opened the annual application process for procedure codes (OPS) in the inpatient sector. Applications can be submitted by medical societies and other associations within the German healthcare system Deadline for applications is February 28th 2018 and the new codes will be incorporated in the OPS version effective from 2019.

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22

Jan 2018

The Institute for Quality and Efficiency in Health Care (IQWiG) has analyzed the applications for approval of clinical trials at the Berlin Ethics Committee. The share of randomized controlled trials (RCTs) had risen to 86% in 2013. This trend is assumed to be an early response to increasing international legal regulations of medical devices requiring manufacturers to present higher standards of evidence.

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10

Jan 2018

The Department of Home Affairs (EDI) in Switzerland decided upon the coverage with evidence development (CED) of two types of positron emission tomography as well as stereotactic radiotherapy (photons) of exudative age-related macular degeneration. The status is given to contested medical services for a specific period which is extended until evidence is complete.

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25

Dec 2017

The Institute for the Hospital Remuneration System (InEK) has opened the proposal procedure for integrating the medical and scientific expertise in the further development of the G-DRG system for the year 2019. Proposals, e.g. add-on payments, DRG re-grouping and changes in coding guidelines or cost calculation can be submitted until March 31st, 2018.

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20

Dec 2017

As part of its routine method evaluation, the Federal Joint Committee (G-BA) charged the German Institute for Quality and Efficiency in Health Care (IQWiG) with a benefit assessment of the use of negative pressure wound therapy (NPWT) compared to conventional methods of wound management in the inpatient sector in Germany. Currently, no restrictions exist for the use of NPWT in hospital settings. Based on the new evaluation report, the G-BA will re-assess the reimbursement status in the statutory health insurance.

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11

Dec 2017

The German Institute for Quality and Efficiency in Health Care (IQWiG) has published its final plan for the benefit assessment of motor-driven movement splints (CPM) after interventions on the knee joint and on the shoulder joint. IQWiG was commissioned with this task by the Federal Joint Committee (G-BA). Two manufacturers and relevant associations had used the opportunity of commenting on the preliminary project plan.

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06

Dec 2017

The Institute for Quality and Efficiency in Health Care (IQWiG), in agreement with the relevant manufacturers' associations, has drafted a model contract to regulate the conditions under which information provided by manufacturers for the evaluation of medical devices is used by IQWiG and made available to third parties.

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29

Nov 2017

Shockwave Medical, the manufacturer of the Coronary Lithoplasty® System for the treatment of calcified coronary artery stenosis, requested a consultation by the Joint Federal Committee (G-BA) to find out whether their device requires an early benefit assessment according to §137h of the Social Code Book V (SGB V). The G-BA decided that the technology is highly invasive and innovative and therefore will need to undergo benefit assessment to be granted innovation funding.

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17

Nov 2017

After successful trial application by a manufacturer (St. Jude Medical, now part of Abbott), the Federal Joint Committee (G-BA) decided to conduct a co-funded study to create evidence about the measurement and monitoring of pulmonary artery pressure using an implanted sensor called “CardioMEMS™ HF System” to optimize therapy in NYHA III heart failure. The G-BA released a trial guideline defining the key points of the planned study, including type and duration of the study, target population and control intervention.

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15

Nov 2017

A manufacturer (PQ Bypass) requested a consultation by the Joint Federal Committee (G-BA) about the eligibility of their medical device for an early benefit assessment according to §137h of the Social Code Book V (SGB V). The technology (PQ Bypass Stent Graft System) is a fully-percutaneous femoral-popliteal bypass procedure for peripheral arterial disease. The G-BA argued that the method is not based on the use of a high-risk medical device and therefore does not have to undergo a §137h assessment.

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02

Nov 2017

Joint Federal Committee (G-BA) evaluated the use of diabetic foot syndrome with hyperbaric oxygen therapy (HBO) as a complementary treatment. Based on studies showing a faster healing process, the G-BA decided to include the method as a benefit in the outpatient sector and expand the indication for the method to a lower severity grade in the inpatient sector.

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31

Oct 2017

Following the request of a patient organization, the Joint Federal Committee (G-BA) evaluated the newborn screening for tyrosinemia type I by tandem mass spectrometry and decided to include the method into the relevant guideline. Before the method can be applied and reimbursed in the statutory health insurance (SHI) in Germany, the Genetic Diagnostics Act requires approval by the Genetic Diagnostics Commission (GEKO).

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11

Oct 2017

German Federal Joint Committee (G-BA) passed directives for co-funded trials to create evidence on two high-intensity focused ultrasound methods that showed potential benefit in the early benefit assessment process in relation to the innovation funding (NUB). Manufacturer refused to cover required contribution to trial costs and thereby risk exclusion of the methods from benefit catalogues in the German social health insurance.

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06

Oct 2017

The Joint Federal Committee (G-BA) resumes assessments of methods that have been intermitted due to missing evidence: LDR brachytherapy in localized prostate carcinoma and PET or PET/CT for malignant lymphomas as well as for interim staging in Hodgkin's lymphoma. Studies conducted in the meantime are expected to provide sufficient evidence base for the assessment about the inclusion of the methods into the social health insurance benefit catalogue in Germany.

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29

Sep 2017

After successful trial application by the manufacturer (Okuvision) of a stimulation technology (Okustim), the Federal Joint Committee (G-BA) decided on a trial guideline for a co-funded study defining the key points of the planned study, including type and time period of the study, target population and control intervention. Results from the trial will be evaluated and may lead to reimbursement of the method in both, the inpatient and outpatient sectors.

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26

Sep 2017

Too little evidence was available to evaluate the efficacy and safety of liposuction for the treatment of lipedema in the inpatient sector in Germany. However, the Federal Joint Committee (G-BA) regards the method as a potential treatment alternative. It, therefore, plans a co-funded trial in cooperation with the manufacturer to create missing evidence with a start in 2018.

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22

Sep 2017

On August 15th, the German Institute of Medical Documentation and Information (DIMDI) published the preliminary version of the new procedure catalogue for the inpatient sector in Germany. The final version of the catalogue will come into effect with the start of the year 2018. MTRC will report about new procedures and other changes included in the catalogue after the release of the official version in the beginning of 2018.

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12

Sep 2017

On 6th of September, the Joint Federal Committee (G-BA) released announcement for manufacturers of OCT equipment to notify about their devices till 4th of October before G-BA makes the final decision about coverage of the procedure in out-patient settings within statutory health insurance. 

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07

Sep 2017

In 2016, Joint Federal Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWIG) for benefit assessment of telemonitoring systems in patients with implantable cardioverter defibrillators (ICD). In July 2017, IQWIG published a preliminary report. Due to lack of evidence, no benefit statement was made.

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24

Aug 2017

G-BA started review process for number of procedures for treatment of benign prostate enlargement in 2009. After publication of the results of rapid health technology assessment by the Institute for Quality and Efficiency in Health Care (IQWiG), G-BA was able to come to the conclusion in June 2017 about efficacy and safety of the thulium laser resection of prostate are well documented and procedure can be covered within statutory health insurance in Germany.

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10

Aug 2017

Article “Cost-utility analysis of bariatric surgery compared with conventional medical management in Germany: a decision analytic modeling” was published in the BMC Surgery. Surgery was found cost-effective at 10-year time horizon and cost saving over life time of operated cohort. Delay in provision of surgery led to reduction of gained health benefits.

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25

Jul 2017

Reinhard Busse et al. published article “Statutory health insurance in Germany: a health system shaped by 135 years of solidarity, self-governance, and competition” in the Lancet. Article provides valuable insights into history and current state of statutory health insurance system in Germany.

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20

Jul 2017

New version 5.0 of the guidance “Allgemeine Methoden” provides basis for the scientific work of the Institute and its external experts. Multiple changes were made to existing sections, several new sections were added as well. Guidance provides brief overview of assessments performed in connection to benefit assessment for high class risk medical technologies, submitted for the innovation funding (NUB) for the first time.

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19

Jul 2017

Researchers evaluated care process, access, administrative efficiency, equity and health care outcomes in 11 countries on the basis of published health care statistics for 72 indicators. The best overall performers among European countries were the UK (ranked 1st), the Netherlands (3rd), Norway (4th), Sweden and Switzerland (6th). Germany (8th) and France (10th) were low in the ranking.

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16

Jun 2017

In March 2017, G-BA approved two additional indications for application of PET/CT for management of neck and head tumors in hospital settings after reevaluation of evidence by IQWiG in 2016. New indications concern decision making about need for neck dissection and laryngoscopic biopsy.

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14

Jun 2017

Recently the Institute for Quality and Efficiency in Health Care (IQWIG) published final report of evaluation extracorporeal shock wave therapy in patients with heel pain. On 31st of May, the Federal Joint Committee (G-BA) requested manufacturers for notification of their devices for extracorporeal shock wave therapy before final decision will be given.

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30

May 2017

The Institute for Quality and Efficiency in Health Care (IQWIG) published final report of evaluation of extracorporeal shock wave therapy in patients with heel. Results demonstrated benefit of the extracorporeal treatment in comparison with placebo, ultrasound and iontophoresis.

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24

May 2017

In 2016, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to perform evaluation of controlled active motion (CAM) in patients with rupture of the anterior cruciate ligament. The final report of assessment was published on May of 2017. No definite conclusion can be made in relation to comparative efficacy and safety of studied technologies due to lack of evidence.

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19

May 2017

In 2014, Federal Joint Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWiG) to conduct health technology assessment of different approaches for lung volume reduction in patients with severe pulmonary emphysema. And now IQWiG has published the final report. The main conclusion is that it was not possible to draw any conclusion about relative effectiveness of bronchoscopic and surgical methods due to lack of the data.

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10

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries of lower extremities with stenting using bare metal and drug-eluting stents for peripheral arterial disease in England, France and Germany. Procedure is reimbursed via combination of diagnosis-related group (DRG) and add-on reimbursement in England and France and solely via DRG in Germany.

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04

May 2017

Check out reimbursement summary for the most established transcatheter mitral valve repair procedure in England, France and Germany. Reimbursement is established in Germany and France (for one indication). It is in process to be established in England and in France (for other indications).

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01

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.

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26

Apr 2017

German Federal Joint Committee (G-BA) has released information about results of benefit assessment (in connection to the §137h SGB V) for two methods: catheter-based lung denervation system for COPD and high-intensity focused ultrasound.

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